IPL Sapphire Ice Cooling Hair Remove Device

Light Based Over-the-counter Hair Removal

Shenzhen Desida Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Desida Technology Co., Ltd. with the FDA for Ipl Sapphire Ice Cooling Hair Remove Device.

Pre-market Notification Details

Device IDK221635
510k NumberK221635
Device Name:IPL Sapphire Ice Cooling Hair Remove Device
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Desida Technology Co., Ltd. 5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoa Shenzhen,  CN 518109
ContactShuangcheng Yuan
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-06
Decision Date2022-08-31

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